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    Clinical Trial Results:
    A 3-part Open-label Study to Assess the Pharmacokinetics of Lanthanum Carbonate, Compare the Efficacy, Safety and Tolerability of 8 Weeks of Treatment With Lanthanum Carbonate and Calcium Carbonate using a Crossover design and Investigate the Efficacy and Safety of 8 Months of Treatment With Lanthanum Carbonate in Hyperphosphataemic Children and Adolescents Aged 10 years to <18 Years With Chronic Kidney Disease on Dialysis

    Summary
    EudraCT number
    2012-000171-17
    Trial protocol
    HU   DE   PL   Outside EU/EEA   CZ   RO  
    Global end of trial date
    16 Nov 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    31 May 2019
    First version publication date
    31 May 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SPD405-207
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01696279
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Shire
    Sponsor organisation address
    300 Shire Way, Lexington, United States, MA 02421
    Public contact
    Study Contact, Shire, 1 866-8425335, ClinicalTransparency@shire.com
    Scientific contact
    Study Contact, Shire, 1 866-8425335, ClinicalTransparency@shire.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-000637-PIP01-09
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    16 Nov 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Nov 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to summarize the percentage of subjects achieving age-specific Kidney Disease Outcomes Quality Initiative (KDOQI) targets for serum phosphorus in hyperphosphatemic children and adolescents with chronic kidney disease (CKD) who were on dialysis, following 8 weeks of treatment with lanthanum carbonate.
    Protection of trial subjects
    This study was conducted in accordance with International Council for Harmonisation of Good Clinical Practice, the principles of the Declaration of Helsinki, as well as other applicable local ethical and legal requirements
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    15 Feb 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Turkey: 8
    Country: Number of subjects enrolled
    Chile: 5
    Country: Number of subjects enrolled
    Czech Republic: 4
    Country: Number of subjects enrolled
    Hungary: 20
    Country: Number of subjects enrolled
    Poland: 11
    Country: Number of subjects enrolled
    Russian Federation: 15
    Worldwide total number of subjects
    63
    EEA total number of subjects
    35
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    14
    Adolescents (12-17 years)
    49
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted at 23 study centers between 15 February 2013 (first subject first visit) and 16 November 2018 (last subject last visit).

    Pre-assignment
    Screening details
    It is a 3 part study (Part 1: Pharmacokinetic assessment, Part 2: (Part 2a-calcium carbonate and lanthanum carbonate [crossover comparison] + Part 2b-lanthanum carbonate], Part 3: lanthanum carbonate treatment for 6 months).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Arm title
    Overall Study
    Arm description
    Study was conducted in 3 parts, subjects aged 10 to 12 years received 500 milligram (mg) and greater than (>) 12 years received 1000 milligram single dose of lanthanum carbonate oral powder respectively during part 1. Followed by part 2 during when subjects received calcium carbonate tablet for 8 weeks until a maximum daily dose of 6500 mg was reached (part 2a-Treatment period 1) and then received lanthanum carbonate oral powder for 8 weeks at a daily dose of 1500 mg was reached (part 2a-Treatment period 2). Eligible subjects received lanthanum carbonate oral powder for 8 weeks at a daily dose of 1500 mg, which was titrated bi-weekly until a daily dose of 3000 mg was achieved (part 2b). Subjects who completed part 2 continued the same treatment for additional 6 months during the part 3.
    Arm type
    Experimental

    Investigational medicinal product name
    Lanthanum carbonate
    Investigational medicinal product code
    SPD405
    Other name
    Fosrenol
    Pharmaceutical forms
    Powder for oral solution in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects aged 10 to 12 years received 500 mg and >12 years received 1000 milligram single dose of lanthanum carbonate oral powder during Part 1 and at a daily dose of 1500 mg in part 2 and 3000 mg in part 3.

    Investigational medicinal product name
    Calcium carbonate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received calcium carbonate until the target serum phosphorus level achieved or until a maximum daily dose of 6500 mg was reached, once the serum phosphorus control was achieved the dose was maintained until the end of 8 week treatment period (Part 2a: treatment period 1).

    Number of subjects in period 1
    Overall Study
    Started
    63
    Subjects started Part 1
    20 [1]
    Subjects entered Part 2
    53
    Subjects entered Part 3
    42
    Completed
    34
    Not completed
    29
         Missing
    1
         Protocol Violation
    1
         Kidney Transplant
    15
         Unspecified
    4
         Consent withdrawn by subject
    1
         Adverse Event
    5
         Non-Compliance with study drug
    2
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Milestone is added here to provide more clarity about the subject movement within the study.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    Study was conducted in 3 parts, subjects aged 10 to 12 years received 500 milligram (mg) and greater than (>) 12 years received 1000 milligram single dose of lanthanum carbonate oral powder respectively during part 1. Followed by part 2 during when subjects received calcium carbonate tablet for 8 weeks until a maximum daily dose of 6500 mg was reached (part 2a-Treatment period 1) and then received lanthanum carbonate oral powder for 8 weeks at a daily dose of 1500 mg was reached (part 2a-Treatment period 2). Eligible subjects received lanthanum carbonate oral powder for 8 weeks at a daily dose of 1500 mg, which was titrated bi-weekly until a daily dose of 3000 mg was achieved (part 2b). Subjects who completed part 2 continued the same treatment for additional 6 months during the part 3.

    Reporting group values
    Overall Study Total
    Number of subjects
    63 63
    Age categorical
    Units: Subjects
        Age group: < 10 years
    3 3
        Age group: ≥10 to <12 years
    11 11
        Age group: ≥12 to <18 years
    49 49
        Age group: ≥18 years
    0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    13.41 ± 2.67 -
    Gender categorical
    Units: Subjects
        Female
    27 27
        Male
    36 36
    Race/Ethnicity, Customized
    Units: Subjects
        White
    61 61
        Black or African American
    0 0
        Native Hawaiian or other Pacific Islander
    0 0
        Asian
    0 0
        American Indian or Alaska Native
    0 0
        Multiple
    2 2
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    5 5
        Not Hispanic or Latino
    58 58
        Unknown or Not Reported
    0 0

    End points

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    End points reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    Study was conducted in 3 parts, subjects aged 10 to 12 years received 500 milligram (mg) and greater than (>) 12 years received 1000 milligram single dose of lanthanum carbonate oral powder respectively during part 1. Followed by part 2 during when subjects received calcium carbonate tablet for 8 weeks until a maximum daily dose of 6500 mg was reached (part 2a-Treatment period 1) and then received lanthanum carbonate oral powder for 8 weeks at a daily dose of 1500 mg was reached (part 2a-Treatment period 2). Eligible subjects received lanthanum carbonate oral powder for 8 weeks at a daily dose of 1500 mg, which was titrated bi-weekly until a daily dose of 3000 mg was achieved (part 2b). Subjects who completed part 2 continued the same treatment for additional 6 months during the part 3.

    Subject analysis set title
    Part 1: Lanthanum Carbonate
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects aged 10 to 12 years received 500 mg and greater than (>) 12 years received 1000 mg single dose of lanthanum carbonate oral powder.

    Subject analysis set title
    Part 2: Calcium Carbonate
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects received calcium carbonate oral tablet until the target serum phosphorus level achieved or until a maximum daily dose of 6500 mg was reached and once serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2a: treatment period 1)

    Subject analysis set title
    Part 2: Lanthanum Carbonate
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, once the serum phosphorus control was achieved the dose was maintained until the end of 8 week (Part 2a: treatment period 2), also subjects received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 week (Part 2b).

    Subject analysis set title
    Part 2 + Part 3: Lanthanum Carbonate
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects received lanthanum carbonate powder at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 week treatment period (Part 2a and Part 2b) and continue to receive lanthanum carbonate for additional 6 months (Part 3).

    Primary: Percentage of Subjects Achieving Age-Specific Kidney Disease Outcomes Quality Initiative (KDOQI) Targets for Serum Phosphate Level Following 8 Weeks of Lanthanum Carbonate Administration (Part 2 + Part 3)

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    End point title
    Percentage of Subjects Achieving Age-Specific Kidney Disease Outcomes Quality Initiative (KDOQI) Targets for Serum Phosphate Level Following 8 Weeks of Lanthanum Carbonate Administration (Part 2 + Part 3) [1]
    End point description
    KDOQI serum phosphorus targets were defined for: Adolescents aged greater than or equal to (>=) 12 to less than (<) 18 years to be less than or equal to (<=) 5.5 milligrams per deciliter (mg/dL) (1.78 millimoles per liter [mmol/L]); Children aged >=10 years to <12 years to be <= 6.0 mg/dL (1.94 mmol/L). Percentage of subjects achieving age-specific KDOQI targets for serum phosphate level was reported only for the subjects who have received lanthanum carbonate during part 2 or part 3. Per-protocol set 2 (PP2) included subjects who had taken at least 1 dose of investigational product and complete 8 weeks of treatment with lanthanum carbonate and who have serum phosphate assessment data available during Part 2 or Part 3 to allow summarizing the percentage of subjects achieving age-specific KDOQI target.
    End point type
    Primary
    End point timeframe
    After 8 weeks of lanthanum carbonate administration
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not performed for this single arm analysis.
    End point values
    Part 2 + Part 3: Lanthanum Carbonate
    Number of subjects analysed
    34
    Units: percentage of subjects
        number (not applicable)
    50
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving Age-Specific Kidney Disease Outcomes Quality Initiative (KDOQI) Targets for Serum Phosphate Level During Part 2

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    End point title
    Percentage of Subjects Achieving Age-Specific Kidney Disease Outcomes Quality Initiative (KDOQI) Targets for Serum Phosphate Level During Part 2
    End point description
    KDOQI serum phosphorus targets was defined for: Adolescents aged >= 12 < 18 years to be <= 5.5 mg/dL (1.78 [mmol/L]); Children aged >=10 years to <12 years to be <= 6.0 mg/dL (1.94 mmol/L). Percentage of subjects achieving age-specific KDOQI targets for serum phosphate level were reported only for the subjects who have received calcium carbonate followed by 8 weeks of treatment with lanthanum carbonate in Part 2.Per Protocol Set 1 (PP1) included subjects who had taken at least 1 dose of investigational product and complete 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who have serum phosphate assessment data available during Part 2 to allow summarizing the percentage of subjects achieving age-specific KDOQI target.
    End point type
    Secondary
    End point timeframe
    Up to 19 weeks
    End point values
    Part 2: Calcium Carbonate Part 2: Lanthanum Carbonate
    Number of subjects analysed
    17
    17
    Units: percentage of subjects
        number (not applicable)
    58.8
    70.6
    No statistical analyses for this end point

    Secondary: Change From Baseline in Serum Phosphorus Levels Following Treatment With Lanthanum Carbonate After 8 Weeks

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    End point title
    Change From Baseline in Serum Phosphorus Levels Following Treatment With Lanthanum Carbonate After 8 Weeks
    End point description
    Changes from baseline in serum phosphorus levels in hyperphosphatemic children and adolescents with chronic kidney disease (CKD) who are on dialysis, following treatment with lanthanum carbonate for 8 weeks were combined and reported baseline was defined as the last assessment prior to the first dose of investigational product. PP2 included subjects who had taken at least 1 dose of investigational product and complete 8 weeks of treatment with lanthanum carbonate and who have serum phosphate assessment data available during Part 2 or Part 3 to allow summarizing the percentage of subjects achieving age-specific KDOQI target.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 8
    End point values
    Part 2 + Part 3: Lanthanum Carbonate
    Number of subjects analysed
    34
    Units: millimole per liter (mmol/L)
        arithmetic mean (standard error)
    -0.334 ± 0.1035
    No statistical analyses for this end point

    Secondary: Change From Baseline in Calcium Levels Following Treatment With Lanthanum Carbonate After Week 8

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    End point title
    Change From Baseline in Calcium Levels Following Treatment With Lanthanum Carbonate After Week 8
    End point description
    Changes from baseline in calcium levels in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with lanthanum carbonate for 8 weeks were reported were combined and reported baseline was defined as the last assessment prior to the first dose of investigational product. PP2 included subjects who had taken at least 1 dose of investigational product and complete 8 weeks of treatment with lanthanum carbonate and who have serum phosphate assessment data available during Part 2 or Part 3 to allow summarizing the percentage of subjects achieving age-specific KDOQI target.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 8
    End point values
    Part 2 + Part 3: Lanthanum Carbonate
    Number of subjects analysed
    34
    Units: millimole per liter (mmol/L)
        arithmetic mean (standard error)
    -0.001 ± 0.0363
    No statistical analyses for this end point

    Secondary: Change From Baseline in Calcium-Phosphorus Product Levels Following Treatment With Lanthanum Carbonate After Week 8

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    End point title
    Change From Baseline in Calcium-Phosphorus Product Levels Following Treatment With Lanthanum Carbonate After Week 8
    End point description
    Changes from baseline in calcium-phosphorus product levels in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with lanthanum carbonate for 8 weeks were reported were combined and reported baseline was defined as the last assessment prior to the first dose of investigational product. PP2 included subjects who had taken at least 1 dose of investigational product and complete 8 weeks of treatment with lanthanum carbonate and who have serum phosphate assessment data available during Part 2 or Part 3 to allow summarizing the percentage of subjects achieving age-specific KDOQI target. millimole square per square liter (mmol^2/L^2)
    End point type
    Secondary
    End point timeframe
    Baseline, Week 8
    End point values
    Part 2 + Part 3: Lanthanum Carbonate
    Number of subjects analysed
    34
    Units: mmol^2/L^2
        arithmetic mean (standard error)
    -0.577 ± 0.2464
    No statistical analyses for this end point

    Secondary: Change From Baseline in Serum Phosphorus Levels Following Treatment With Calcium Carbonate After 8 Weeks and Lanthanum Carbonate After 8 Weeks During Part 2

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    End point title
    Change From Baseline in Serum Phosphorus Levels Following Treatment With Calcium Carbonate After 8 Weeks and Lanthanum Carbonate After 8 Weeks During Part 2
    End point description
    Changes from baseline in serum phosphorus levels in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with calcium carbonate after 8 weeks and lanthanum carbonate after 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. PP1 included subjects who had taken at least 1 dose of investigational product and complete 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who have serum phosphate assessment data available during Part 2 to allow summarizing the percentage of subjects achieving age-specific KDOQI target.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 8
    End point values
    Part 2: Calcium Carbonate Part 2: Lanthanum Carbonate
    Number of subjects analysed
    16
    17
    Units: millimole per liter (mmol/L)
        arithmetic mean (standard error)
    -0.520 ± 0.1786
    -0.467 ± 0.1312
    No statistical analyses for this end point

    Secondary: Change From Baseline in Calcium Levels Following Treatment With Calcium Carbonate After 8 Weeks and Lanthanum Carbonate After 8 Weeks During Part 2

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    End point title
    Change From Baseline in Calcium Levels Following Treatment With Calcium Carbonate After 8 Weeks and Lanthanum Carbonate After 8 Weeks During Part 2
    End point description
    Changes from baseline in calcium levels in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with calcium carbonate after 8 weeks and lanthanum carbonate after 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. PP1 included subjects who had taken at least 1 dose of investigational product and complete 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who have serum phosphate assessment data available during Part 2 to allow summarizing the percentage of subjects achieving age-specific KDOQI target.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 8
    End point values
    Part 2: Calcium Carbonate Part 2: Lanthanum Carbonate
    Number of subjects analysed
    16
    17
    Units: millimole per liter (mmol/L)
        arithmetic mean (standard error)
    0.058 ± 0.0554
    -0.009 ± 0.0574
    No statistical analyses for this end point

    Secondary: Change From Baseline in Calcium-Phosphorus Product Levels Following Treatment With Calcium Carbonate After 8 Weeks and Lanthanum Carbonate After 8 Weeks During Part 2

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    End point title
    Change From Baseline in Calcium-Phosphorus Product Levels Following Treatment With Calcium Carbonate After 8 Weeks and Lanthanum Carbonate After 8 Weeks During Part 2
    End point description
    Changes from baseline in calcium-phosphorus product levels in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with calcium carbonate after 8 weeks and lanthanum carbonate after 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. PP1 included subjects who had taken at least 1 dose of investigational product and complete 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who have serum phosphate assessment data available during Part 2 to allow summarizing the percentage of subjects achieving age-specific KDOQI target.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 8
    End point values
    Part 2: Calcium Carbonate Part 2: Lanthanum Carbonate
    Number of subjects analysed
    16
    17
    Units: mmol^2/L^2
        arithmetic mean (standard error)
    -0.966 ± 0.4084
    -0.669 ± 0.3834
    No statistical analyses for this end point

    Secondary: Change From Baseline in Serum Phosphorus Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3

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    End point title
    Change From Baseline in Serum Phosphorus Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3
    End point description
    Change from baseline in serum phosphorus levels at the last visit of each 8-week treatment period during Part 2 and monthly during the 6-month extension phase (Part 3) were reported. Baseline was defined as the last assessment prior to the first dose of investigational product. PP2 included subjects who had taken at least 1 dose of investigational product and complete 8 weeks of treatment with lanthanum carbonate and who have serum phosphate assessment data available during Part 2 or Part 3 to allow summarizing the percentage of subjects achieving age-specific KDOQI target. Here, n = number of subjects evaluable at the specific category time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 8, 12, 16, 20, 24, 28 and Week 32
    End point values
    Part 2 + Part 3: Lanthanum Carbonate
    Number of subjects analysed
    34
    Units: millimole per liter (mmol/L)
    arithmetic mean (standard deviation)
        Change at Week 8 (n = 34)
    -0.334 ± 0.1035
        Change at Week 12 (n = 30)
    -0.416 ± 0.0912
        Change at Week 16 (n = 27)
    -0.314 ± 0.1278
        Change at Week 20 (n = 25)
    -0.316 ± 0.1055
        Change at Week 24 (n = 23)
    -0.322 ± 0.1356
        Change at Week 28 (n = 20)
    -0.236 ± 0.1491
        Change at Week 32 (n= 13)
    -0.143 ± 0.1558
    No statistical analyses for this end point

    Secondary: Change From Baseline in Calcium Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3

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    End point title
    Change From Baseline in Calcium Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3
    End point description
    Change from baseline in calcium levels at the last visit of each 8-week treatment period during Part 2 and monthly during the 6- month extension phase (Part 3) were reported.Baseline was defined as the last assessment prior to the first dose of investigational product. PP2 included subjects who had taken at least 1 dose of investigational product and complete 8 weeks of treatment with lanthanum carbonate and who have serum phosphate assessment data available during Part 2 or Part 3 to allow summarizing the percentage of subjects achieving age-specific KDOQI target. Here, n = number of subjects evaluable at the specific category time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 8, 12, 16, 20, 24, 28 and Week 32
    End point values
    Part 2 + Part 3: Lanthanum Carbonate
    Number of subjects analysed
    34
    Units: millimole per liter (mmol/L)
    arithmetic mean (standard error)
        Change at Week 8 (n = 34)
    -0.001 ± 0.0363
        Change at Week 12 (n = 28)
    -0.045 ± 0.0475
        Change at Week 16 (n = 26)
    -0.034 ± 0.0534
        Change at Week 20 (n = 22)
    0.003 ± 0.0511
        Change at Week 24 (n = 22)
    -0.010 ± 0.0450
        Change at Week 28 (n = 20)
    0.049 ± 0.0623
        Change at Week 32 (n = 13)
    -0.127 ± 0.0773
    No statistical analyses for this end point

    Secondary: Change From Baseline in Calcium-Phosphorus Product Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3

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    End point title
    Change From Baseline in Calcium-Phosphorus Product Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3
    End point description
    Change from baseline in calcium-phosphorus product levels at the last visit of each 8-week treatment period during Part 2 and monthly during the 6-month extension phase (Part 3) were reported.Baseline was defined as the last assessment prior to the first dose of investigational product.PP2 included subjects who had taken at least 1 dose of investigational product and complete 8 weeks of treatment with lanthanum carbonate and who have serum phosphate assessment data available during Part 2 or Part 3 to allow summarizing the percentage of subjects achieving age-specific KDOQI target. Here, n = number of subjects evaluable at the specific category time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 8, 12, 16, 20, 24, 28 and Week 32
    End point values
    Part 2 + Part 3: Lanthanum Carbonate
    Number of subjects analysed
    34
    Units: mmol^2/L^2
    arithmetic mean (standard error)
        Change at Week 8 (n = 34)
    -0.577 ± 0.2464
        Change at Week 12 (n = 28)
    -0.783 ± 0.2535
        Change at Week 16 (n = 26)
    -0.575 ± 0.3023
        Change at Week 20 (n = 22)
    -0.362 ± 0.2711
        Change at Week 24 (n = 22)
    -0.578 ± 0.3459
        Change at Week 28 (n = 20)
    -0.326 ± 0.3767
        Change at Week 32 (n = 13)
    -0.570 ± 0.3624
    No statistical analyses for this end point

    Secondary: Change From Baseline in Biochemical Bone Markers

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    End point title
    Change From Baseline in Biochemical Bone Markers
    End point description
    Change from baseline in bone turnover markers including bone alkaline phosphatase (ALP), osteocalcin, and sclerostin was reported for combined Part 2 and 3. PP1 included subjects who had taken at least 1 dose of investigational product and complete 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who have serum phosphate assessment data available during Part 2 to allow summarizing the percentage of subjects achieving age-specific KDOQI target. End of study is the completion if the subjects has benefited from and desires to continue dosing with lanthanum. Here,'99999' in the reported data indicate that the respective subject analysis set was not applicable to the category and n = number of subjects evaluable for each subject analysis set at the specific category time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 8, Week 16 and EOS
    End point values
    Part 2: Calcium Carbonate Part 2 + Part 3: Lanthanum Carbonate
    Number of subjects analysed
    17
    17
    Units: microgram per liter (ug/L)
    arithmetic mean (standard error)
        ALP: Change at Week 8 (n = 16, 0)
    -0.78 ± 8.503
    99999 ± 99999
        ALP: Change at Week 16 (n = 0, 15)
    99999 ± 99999
    31.86 ± 16.334
        ALP: Change at EOS (n = 0, 13)
    99999 ± 99999
    59.12 ± 20.822
        Osteocalcin: Change at Week 8 (n = 16, 0)
    8.2 ± 20.24
    99999 ± 99999
        Osteocalcin: Change at Week 16 (n = 0, 15)
    99999 ± 99999
    10.3 ± 21.57
        Osteocalcin: Change at EOS (n = 0, 13)
    99999 ± 99999
    94.0 ± 32.60
        Sclerostin: Change at Week 8 (n = 12, 0)
    0.146 ± 0.1380
    99999 ± 99999
        Sclerostin: Change at Week 16 (n = 0, 13)
    99999 ± 99999
    -0.062 ± 0.0946
        Sclerostin: Change at EOS (n = 0, 11)
    99999 ± 99999
    -0.051 ± 0.1037
    No statistical analyses for this end point

    Secondary: Change From Baseline in Biochemical Bone Markers for Tartrate-Resistant Acid Phosphatase (TRAP)

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    End point title
    Change From Baseline in Biochemical Bone Markers for Tartrate-Resistant Acid Phosphatase (TRAP)
    End point description
    Change from baseline in bone turnover markers for, tartrate-resistant acid phosphatase (TRAP) was reported for combined Part 2 and 3. PP1 included subjects who had taken at least 1 dose of investigational product and complete 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who have serum phosphate assessment data available during Part 2 to allow summarizing the percentage of subjects achieving age-specific KDOQI target. Here,'99999' in the reported data indicate that the respective subject analysis set was not applicable to the category and n = number of subjects evaluable for each subject analysis set at the specific category time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 8, Week 16 and EOS
    End point values
    Part 2: Calcium Carbonate Part 2 + Part 3: Lanthanum Carbonate
    Number of subjects analysed
    17
    17
    Units: Unit per liter (U/L)
    arithmetic mean (standard error)
        Change at Week 8 (n = 16, 0)
    -1.71 ± 1.141
    99999 ± 99999
        Change at Week 16 (n = 0, 15)
    99999 ± 99999
    1.95 ± 1.173
        Change at EOS (n = 0, 13)
    99999 ± 99999
    4.65 ± 1.934
    No statistical analyses for this end point

    Secondary: Change From Baseline in Biochemical Bone Markers for Fibroblast Growth Factor 23 (FGF-23)

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    End point title
    Change From Baseline in Biochemical Bone Markers for Fibroblast Growth Factor 23 (FGF-23)
    End point description
    Change from baseline in bone turnover markers including fibroblast growth factor 23 (FGF-23) was reported for combined Part 2 and 3. PP1 included subjects who had taken at least 1 dose of investigational product and complete 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who have serum phosphate assessment data available during Part 2 to allow summarizing the percentage of subjects achieving age-specific KDOQI target. Here,'99999' in the reported data indicate that the respective subject analysis set was not applicable to the category and n = number of subjects evaluable for each subject analysis set at the specific category time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 8, Week 16 and EOS
    End point values
    Part 2: Calcium Carbonate Part 2 + Part 3: Lanthanum Carbonate
    Number of subjects analysed
    17
    17
    Units: relative unit per milliliter (RU/ml)
    arithmetic mean (standard error)
        Change at Week 8 (n = 16, 0)
    5130.3 ± 5232.21
    99999 ± 99999
        Change at Week 16 (n = 0, 15)
    99999 ± 99999
    -8162.4 ± 5274.60
        Change at EOS (n = 0, 13)
    99999 ± 99999
    -251.1 ± 1736.51
    No statistical analyses for this end point

    Secondary: Change From Baseline in Biochemical Bone Markers for Parathyroid Hormone (PTH)

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    End point title
    Change From Baseline in Biochemical Bone Markers for Parathyroid Hormone (PTH)
    End point description
    Change from baseline in bone turnover markers for parathyroid hormone was reported for combined Part 2 and 3. PP1 included subjects who had taken at least 1 dose of investigational product and complete 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who have serum phosphate assessment data available during Part 2 to allow summarizing the percentage of subjects achieving age-specific KDOQI target. Here,'99999' in the reported data indicate that the respective subject analysis set was not applicable to the category and n = number of subjects evaluable for each subject analysis set at the specific category time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 8, Week 16 and EOS
    End point values
    Part 2: Calcium Carbonate Part 2 + Part 3: Lanthanum Carbonate
    Number of subjects analysed
    17
    17
    Units: picomole per liter (pmol/L)
    arithmetic mean (standard error)
        Change at Week 8 (n = 16, 0)
    -7.132 ± 9.7669
    99999 ± 99999
        Change at Week 16 (n = 0, 15)
    99999 ± 99999
    16.273 ± 12.5441
        Change at EOS (n = 0, 13)
    99999 ± 99999
    59.801 ± 16.3097
    No statistical analyses for this end point

    Secondary: Change From Baseline in Biochemical Bone Markers for fetuin-A

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    End point title
    Change From Baseline in Biochemical Bone Markers for fetuin-A
    End point description
    Change from baseline in bone turnover markers for fetuin-A was reported for combined Part 2 and 3. PP1 included subjects who had taken at least 1 dose of investigational product and complete 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who have serum phosphate assessment data available during Part 2 to allow summarizing the percentage of subjects achieving age-specific KDOQI target. Here,'99999' in the reported data indicate that the respective subject analysis set was not applicable to the category and n = number of subjects evaluable for each subject analysis set at the specific category time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 8, Week 16 and EOS
    End point values
    Part 2: Calcium Carbonate Part 2 + Part 3: Lanthanum Carbonate
    Number of subjects analysed
    17
    17
    Units: gram per liter (g/L)
    arithmetic mean (standard error)
        Change at Week 8 (n = 12, 0)
    -0.006 ± 0.0301
    99999 ± 99999
        Change at Week 16 (n = 0, 13)
    99999 ± 99999
    0.037 ± 0.0360
        Change at EOS (n = 0, 11)
    99999 ± 99999
    0.039 ± 0.0273
    No statistical analyses for this end point

    Secondary: Change From Baseline in Height

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    End point title
    Change From Baseline in Height
    End point description
    Change from baseline in height for combined Part 2 and Part 3 for each drug at Week 8, 16 and end of study was reported. PP1 included subjects who had taken at least 1 dose of investigational product and complete 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who have serum phosphate assessment data available during Part 2 to allow summarizing the percentage of subjects achieving age-specific KDOQI target. Here,'99999' in the reported data indicate that the respective subject analysis set was not applicable to the category and n = number of subjects evaluable for each subject analysis set at the specific category time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 8, Week 16, and EOS
    End point values
    Part 2: Calcium Carbonate Part 2 + Part 3: Lanthanum Carbonate
    Number of subjects analysed
    17
    17
    Units: centimeter (cm)
    arithmetic mean (standard error)
        Change at Week 8 (n = 17, 0)
    0.7 ± 0.39
    99999 ± 99999
        Change at Week 16 (n = 0, 17)
    99999 ± 99999
    0.6 ± 0.25
        Change at EOS (n = 0, 13)
    99999 ± 99999
    1.3 ± 0.46
    No statistical analyses for this end point

    Secondary: Change From Baseline in Weight

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    End point title
    Change From Baseline in Weight
    End point description
    Change from baseline in weight for combined Part 2 and Part 3 for each drug at Week 8, 16 and end of study (EOS) was reported. PP1 included subjects who had taken at least 1 dose of investigational product and complete 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who have serum phosphate assessment data available during Part 2 to allow summarizing the percentage of subjects achieving age-specific KDOQI targets. Here,'99999' in the reported data indicate that the respective subject analysis set was not applicable to the category and n = number of subjects evaluable for each subject analysis set at the specific category time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 8, Week 16, and EOS
    End point values
    Part 2: Calcium Carbonate Part 2 + Part 3: Lanthanum Carbonate
    Number of subjects analysed
    17
    17
    Units: kilogram (Kg)
    arithmetic mean (standard error)
        Change at Week 8 (n = 17, 0)
    1.18 ± 0.524
    99999 ± 99999
        Change at Week 16 (n = 0, 17)
    99999 ± 99999
    1.09 ± 0.358
        Change at EOS (n = 0, 13)
    99999 ± 99999
    2.86 ± 0.606
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From start of study drug administration up to follow-up (up to Week 42)
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Part 1: Lanthanum Carbonate
    Reporting group description
    Subjects aged 10 to 12 years received 500 mg and >12 years received 1000 mg single dose of lanthanum carbonate oral powder.

    Reporting group title
    Part 2 + Part 3: Lanthanum Carbonate
    Reporting group description
    Subjects received lanthanum carbonate powder at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 week treatment period (Part 2a and Part 2b) and continue to receive lanthanum carbonate for additional 6 months (Part 3).

    Reporting group title
    Part 2: Calcium Carbonate
    Reporting group description
    Subjects received calcium carbonate oral tablet until the target serum phosphorus level achieved or until a maximum daily dose of 6500 mg was reached and once serum phosphorus control was achieved the dose was maintained until the end of 8 weeks.

    Serious adverse events
    Part 1: Lanthanum Carbonate Part 2 + Part 3: Lanthanum Carbonate Part 2: Calcium Carbonate
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    19 / 52 (36.54%)
    9 / 53 (16.98%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 52 (1.92%)
    2 / 53 (3.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Arteriovenous fistula site haemorrhage
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 52 (1.92%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arteriovenous fistula thrombosis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 52 (1.92%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Graft haemorrhage
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 52 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 52 (1.92%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Blood phosphorus
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 52 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 52 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 52 (1.92%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleurisy
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 52 (1.92%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary haemorrhage
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 52 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Device occlusion
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 52 (1.92%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombosis in device
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 52 (1.92%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 52 (1.92%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 52 (1.92%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 52 (1.92%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatitis acute
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 52 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 52 (1.92%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteochondrosis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 52 (1.92%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Fluid overload
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 52 (1.92%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolic disorder
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 52 (1.92%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis perforated
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 52 (1.92%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Catheter site infection
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 52 (1.92%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 52 (3.85%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 52 (1.92%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 20 (0.00%)
    5 / 52 (9.62%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 52 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Part 1: Lanthanum Carbonate Part 2 + Part 3: Lanthanum Carbonate Part 2: Calcium Carbonate
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 20 (10.00%)
    32 / 52 (61.54%)
    25 / 53 (47.17%)
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 52 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 52 (0.00%)
    2 / 53 (3.77%)
         occurrences all number
    0
    0
    3
    Nausea
         subjects affected / exposed
    1 / 20 (5.00%)
    3 / 52 (5.77%)
    2 / 53 (3.77%)
         occurrences all number
    1
    5
    2
    Vomiting
         subjects affected / exposed
    1 / 20 (5.00%)
    5 / 52 (9.62%)
    1 / 53 (1.89%)
         occurrences all number
    1
    6
    2
    Metabolism and nutrition disorders
    Hypercalcaemia
         subjects affected / exposed
    0 / 20 (0.00%)
    5 / 52 (9.62%)
    9 / 53 (16.98%)
         occurrences all number
    0
    9
    9
    Hyperphosphataemia
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 52 (0.00%)
    2 / 53 (3.77%)
         occurrences all number
    0
    0
    2
    Hypocalcaemia
         subjects affected / exposed
    0 / 20 (0.00%)
    3 / 52 (5.77%)
    3 / 53 (5.66%)
         occurrences all number
    0
    6
    3
    Hypophosphataemia
         subjects affected / exposed
    0 / 20 (0.00%)
    6 / 52 (11.54%)
    3 / 53 (5.66%)
         occurrences all number
    0
    10
    4
    Infections and infestations
    Influenza
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 52 (1.92%)
    2 / 53 (3.77%)
         occurrences all number
    0
    1
    2
    Nasopharyngitis
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 52 (3.85%)
    2 / 53 (3.77%)
         occurrences all number
    0
    3
    2
    Respiratory tract infection
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 52 (3.85%)
    3 / 53 (5.66%)
         occurrences all number
    0
    2
    4
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 20 (0.00%)
    5 / 52 (9.62%)
    0 / 53 (0.00%)
         occurrences all number
    0
    5
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Jul 2012
    Amendment 1 included the following changes - Addition of sclerostin and fetuin-A parameters to the assay for biochemical bone markers. Correction of error in dosing regimen in Parts 1 and 2. Clarification and correction of washout periods, and assessments required. Addition of guidance language in relation to dosing in case of hypophosphatemia and/or hypocalcemia during Parts 2 and 3 or hypercalcemia while taking calcium carbonate in Part 2. PTH designated as a biochemical bone marker but was to be analyzed as part of the routine biochemistry panel. Biochemistry parameters amended to include vitamin D at baseline and end of study.
    24 Sep 2012
    Amendment 2 included the following changes - Addition of confirmatory phosphorus value to washout period visits W1 and W2. Clarification that subjects may start lanthanum carbonate treatment at Visit 2.4 if phosphorus criterion is met. Confirmation that subjects will not be withdrawn from the study if they do not meet phosphorus criteria after Visit 2.4 but will start lanthanum carbonate therapy and be assessed for Part 3. These subjects cannot be included in the per-protocol set. Correction that lanthanum carbonate is taken with meals. Clarification of which secondary endpoints (height or length, head circumference, and weight) are to be measured at subject visits.
    17 Apr 2014
    Amendment 3 included the following changes - Age range amended from 6 months to <18 years to 10 years to <18 years. Reduction in Part 3 from 10 months to 6 months and overall exposure to lanthanum reduced from 12 months to 8 months. Change in serious adverse events and pregnancy notification from 1 business day to 24 hours. Extension in safety follow-up period from 7 days after last visit to 7-14 days from the last dose of investigational product, except for subjects who undergo kidney transplant, whose follow-up telephone call will be 30+/-7 days after the last dose of investigational product. Added that calcium levels, in addition to phosphorus levels, should be measured locally for titration purposes during the first treatment period of Part 2. Removal of exclusion criterion relating to serum calcium level. Starting dose of lanthanum carbonate in the second treatment period of Part 2 amended to reflect the change in age range of subjects. All subjects to be given a 1500 mg starting dose. Clarification that the lanthanum carbonate given in Parts 2 and 3 should be mixed with food and divided equally between all meals. Clarification that titration should continue until serum phosphorus levels meet KDOQI age guidelines. Correction made to age range of subjects with phosphorus level >6.0 mg/dL. Clarified acceptable dose levels in Part 3. Clarified how the per-protocol set will be determined. Sample size justification added. Study period extended to December 2015.
    02 Mar 2015
    Amendment 4 included the following changes - Protocol revised to match updated SAP (Redefined full analysis set, Redefined Safety Analysis Set 3, Described subject disposition for all study parts, Described summarization methods for demographic and baseline characteristics (updated to align with finalized SAP), Described intent for listing and analyzing investigational product exposure, Described methods for listing prior and concomitant medication, Described safety analyses). Updated study duration to 44 months (extended to 2016).
    18 Oct 2016
    Amendment 5 included the following changes - Removed the active comparator (calcium carbonate) treatment arm given the extreme difficulty in recruiting enough subjects to obtain the originally proposed sample size of at least 50 subjects required for the per-protocol set for a crossover non-inferiority study. The original design of Part 2 of Study SPD405-207 was crossover non-inferiority to allow a formal comparison of the efficacy of lanthanum carbonate with calcium carbonate (Part 2a). Under the modified study design, Part 2a has been removed and subjects will only be treated with 8 weeks of lanthanum carbonate in Part 2b of the study for short-term efficacy and safety assessment. Adjusted planned sample size from 72 to 65, with the target to enroll at least 35 subjects (instead of at least 50) who complete 8 weeks of treatment with lanthanum carbonate and are assessable for the primary endpoint, due to low replenishment of eligible subjects and the discontinuation of subjects enrolled in the study, in agreement with Paediatric Committee of the European Medicine Agency. Added that Part 1, single dose, pharmacokinetic assessment of lanthanum carbonate, is complete and the interim clinical study report interpreting and summarizing the data is available. Added or modified the primary and secondary objectives. As a result of the change in the study design, it is no longer necessary to replace subjects who discontinue Part 2 to ensure that 35 subjects enter Part 3 of the study. Updated study duration to 64 months (extended to 2018). Modified or redefined analysis populations. Clarified that the full analysis set and PP2 will be used for the primary endpoint analyses, while the FAS, PP1, and PP2 will be used for the secondary efficacy endpoint analyses. Updated primary and secondary variables to align with the changes made to the primary and secondary objectives and to the definition of analysis populations. Adjusted the planned sample size.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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